Curcumin and Function in Older Adults

NCT03085680 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB201600334-NP30AG028740IRB201701371
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

This placebo-controlled RCT tests whether dietary supplementation with curcumin maintains or improves cognitive and physical function in older adults who are at high risk of functional decline due existing (mild) functional impairments and elevated biomarkers of inflammation and explore the association between functional changes and changes in biological indicators of active inflammation.

Conditions

Older Adults; Physical Function; Cognitive Function

Keywords

Curcumin, physical function, cognitive function

Outcome Measures

Primary Outcomes (2)

• Curcumin and Physical Function -Walking

  To examine the effects of dietary supplementation with curcumin on changes in physical function walking speed- 400meter walk test.

  Change in walking speed (meters/second) from Baseline and 3 months

• Curcumin and Physical Function - Hand Grip

  To examine the effects of dietary supplementation with curcumin on changes in physical function grip strength- hand dynamometer

  Change in grip strength (kilograms) from Baseline and 3 months

Secondary Outcomes (3)

• Curcumin and Cognitive Function - Attention & Memory

  Change in attention from Baseline and 3 months

• Curcumin and Pain

  Baseline and 3 months

• Curcumin and Inflammation - Interleukin-6

  From Baseline and 3 months

Study Arms (2)

Curcumin

EXPERIMENTAL

Participants will be given identical capsules containing curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.

Drug: Curcumin

Placebo

PLACEBO COMPARATOR

Participants will be given identical capsules containing placebo (microcrystalline cellulose) and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.

Drug: microcrystalline cellulose

Interventions

Curcumin DRUG

Participants will be given curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.

Also known as: Turmeric, C3 Complex

Curcumin

microcrystalline cellulose DRUG

Participants will be instructed to consume two capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 65 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age \> 65 years
• Usual walking speed \<1 m/sec and \>0.44 m/sec on the 4 m walk
• Sedentary lifestyle (\< 120 min per week of moderate intensity physical activity);
• CRP \> 1.0 mg/dL
• Willingness and ability to give informed consent
• Willingness to be randomized to the intervention groups
• Availability for participation through duration of study

You may not qualify if:

• Unable to complete 400 meter walk test
• Failure or inability to provide informed consent
• Residence in a Skilled Nursing Facility (SNF); residence in an Assisted Living Facility (ALF) or independent housing is allowed
• Self-reported inability to walk one block
• Blood pressure readings \>160/100
• Significant cognitive impairment, defined as a known diagnosis of dementia, or a Mini-Mental State Exam (MMSE) score \<24
• Unable to communicate because of severe hearing loss or speech disorder
• Clinically significant depression (CES-D score \> 20)
• Severe cardiac disease, including NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
• Severe pulmonary disease, pneumonitis or interstitial lung disease
• Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)
• Neurological conditions that cause impaired muscle function or mobility (e.g., Parkinson's Disease, multiple sclerosis, ALS)
• Other significant co-morbid medical disease (e.g. renal failure with eGFR \< 30 ml/minute or on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia)
• Terminal illness with life expectancy less than 12 months, as determined by a physician
• Excessive alcohol use, defined as more than 5 drinks/day for males or more than 4 drinks/day for females, or more than 14 drinks per week

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32611, United States

Location

MeSH Terms

Interventions

Curcumin; microcrystalline cellulose

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Results Point of Contact

• Title: Dr. Robert Mankowski
• Organization: University of Florida

r.mankowski@ufl.edu

+1 (352) 294-5055

Study Officials

• Stephen D Anton, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized placebo-controlled design.

Study Record Dates

• First Submitted: March 15, 2017
• First Posted: March 21, 2017
• Study Start: August 11, 2017
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: July 26, 2022
• Results First Posted: February 2, 2022

Record last verified: 2022-07

Locations

US (1)